EMA Adds New Excipients to Labeling Requirements

The European Medicines Agency (EMA) updated on Monday its annex to the European Commission guidelines on the labeling of excipients, adding five new excipients and extending the safety warnings required for 10 others.

Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are considered inactive, although some may cause reactions under certain circumstances. For example, lactose is commonly used as a filler in tablets, but may cause reactions in patients lactose intolerant.

This document lists excipients known to have a recognized action or effect and is to be declared on the label and package leaflet, is being updated for the first time since its publication in 2003.

The update also comes at a time when the European Commission is considering revising its guidelines on the labeling of excipients following a public consultation that ended in May.

The five newly listed excipients include boric acid, cyclodextrins, phosphate buffers, sodium laurilsulfate and perfumes containing allergens. The appendix includes an appendix listing 26 specific perfume allergens such as cinnamon and oak moss that must be included in the labeling.

Regarding new safety information, the EMA indicates that the revised Annex "pays particular attention to ... the safety of these excipients when used in children or pregnant women". For example, the appendix contains new safety information that should be included in the package leaflet for benzyl alcohol-containing medicines that advise pregnant or lactating women to consult with their doctor or pharmacist before taking the drug.

The EMA indicates that the revised Annex enters into force immediately for all centrally and nationally authorized medicinal products and that current marketing authorization holders are required to update the labeling of their products at the first opportunity. For products that are not subject to regulation, the EMA indicates that developers are required to submit a Type IB variant detailing labeling changes over the next three years